Principal, Medical Writer

Role: Principal Clinical Medical Writer responsible for developing and overseeing medical documentation in clinical development programs for rare genetic diseases, including therapies for conditions like MPS, Fabry, and Pompe. Objectives: improve documentation quality, standardize processes, and support regulatory submissions. Responsibilities: authoring and editing protocols, clinical study reports, safety reports, and regulatory documents; managing medical writing staff; coordinating cross-functional review processes; ensuring compliance with industry standards; and contributing to process improvements. Requirements: MS or higher degree in a scientific discipline; extensive experience in clinical medical writing, including regulatory documents such as INDs, NDAs, protocols, and safety reports; proven project management skills; knowledge of clinical research concepts, drug development stages, and regulatory guidelines (eCTD, ICH, FDA). Preferred: certifications from industry medical writing associations; prior management experience in a clinical development setting. High-Value: focus on rare diseases, biologics or small molecules, late-stage development (clinical trial conduct and regulatory filings), cross-functional collaboration, and remote/hybrid work setup with some onsite requirement near California. Travel: not specified.